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FDA Recall Alert: Hospira Announces Voluntary Recall of One Lot of 0.25 Percent Marcaine, Bupivacaine HCI Injection, USP, Due to Visible Particulates

From ASCRS/ASOA Bulletin:

The Food and Drug Administration (FDA) alerted providers that Hospira, Inc. is conducting a nationwide recall of one lot of 0.25% Marcaine, Bupivacaine HCI Injection, USP, 10ml, single-dose vial, preservative-free to the user level due to a confirmed customer report of discolored solution with visible particles embedded in the glass as well as discolored solution.

Hospira has attributed the embedded particulate to a supplier’s glass defect and is working with its supplier on implementing corrective and preventive actions.

Risk factors associated with the particulate include local inflammation, mechanical disruption of tissue, immune response to the particulate and delay in therapy. While extremely rare, particulate exposed to strong magnetic fields could potentially dislodge and cause tissue damage.

Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. This lot, Lot # 34-440-DD, was distributed nationwide to distributors, wholesalers, hospitals and clinics from December 2013 through January 2014. The lot expires on July 1, 2015.

Customers are advised to check inventory and immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification.

Hospira will be notifying its direct distributors and customers via a recall letter and will arrange for impacted product to be returned to Stericycle, which can be contacted at 1-877-546-7642. For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187. To report adverse events, contact Hospira Global Compliant Management at 1-800-441-4100.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by mail or by fax.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Mail or fax: download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

If you need additional information, please contact Ashley McGlone, manager of regulatory affairs, at amcglone@ascrs.org or 703-591-2220.